Scope:
The guidance is applied to M.5925 Soft (hydrophilic) contact lens. These lenses are flexible, rely on outer support to remain in shape. They are made of various polymer materials, the main polymer molecules of which absorb or attract a certain volume (percentage) of water. Some common materials include hydrogel and silicone elastomer.

Product description and specification:
Manufactures or brand owners should provide the following information:
1. Materials of the lens: Monomer, crosslinking agent, initiator, color, color additive, UV absorber, and the proportion of all ingredients. In addition, whether the color additive pigment is approved by FDA should be further expressed.

2. Manufacturing processes: Manufacture method (E.g. cast-mold, lathe-cut, spin-cast), polymerization, annealing condition (E.g. time and temperature), main process, sterilization method, tinting process, lens structure, and packaging material.

3. Finished lens parameters: Diopter, base curve, diameter, center thickness, cylinder power, cylinder axis, and addition power.

4. Physicochemical properties: Color/light transmittance, refractive index, water content, and oxygen permeability. Whether the unit and test methods are being amended through applying boundary layer effects and edge effects should be further expressed.

5. Mechanical properties: Modulus, Tensile strength, Elongation at break, and toughness.

Safety and performance data:

If any of the tests below were not performed, related literature or scientific evaluation report should be submitted to confirm product safety and performance. If the applied testing methods were different from those listed in references, (1) for the ones possess equivalence, methods should be submitted for audit, (2) for the ones without equivalence, methods along with related literature or scientific evaluation report should be submitted to explain the establish basis of the methods. 

	Items	Specifications
1	Biocompatibility Test	Acute systemic toxicity
		Ocular study with rabbit eyes
		Cytotoxicity
		Preservative uptake and release  (using unapproved UV absorbent)
		Guinea pig maximization test (using unapproved UV absorbent)
		3 weeks ocular irritation test in rabbits (using unapproved UV absorbent)
		Carcinogenicity (using unapproved color additive pigment)
		Guinea pig maximization test (using unapproved color additive pigment)
		3 weeks ocular irritation test in rabbits (using unapproved color additive pigment)
		28-day repeated instillation ocular irritation test (using unapproved color additive pigment)
2	Sterilization Validation	Sterility assurance level should be less than 10-6
3	Finished Lens Parameters	Appearance
		Base curve radius
		Back vertex power
		Cylinder power
		Cylinder axis
		Total diameter
		Center thickness
		Prismatic power
4	Physicochemical properties of Contact Lens materials	O2 permeability
		Luminous transmittance
		UV radiation transmittance (for products claim to be UV-resistant)
		Refractive index
		Water content
		Extractables
		Color additive extraction  (for colorant-adding products)
		Compatible with care system (for products claim to cooperate with specific cleaning systems)
5	Shelf Life	Shelf life test should be tested.

RECOMMEND READING

- TFDA Published Guidance for Applying Human Factors/Usability Engineering Evaluation to Medical Devices - TFDA Release Guidance for Pre-clinical Testing of Power Kits on Mechanical Wheelchair

References:
公告修正「軟式隱形眼鏡」臨床前測試基準